Food Safety

FDA approves radiation-based prostate cancer drug

1 day ago

The FDA said Wednesday it approved the drug, Xofigo from Bayer Pharmaceuticals, for men whose cancer has grown into bone tumors even after receiving medication or surgery to lower testosterone.

FDA approves genetic test for lung cancer drug

3 days ago

The Food and Drug Administration on Tuesday approved a genetic test from Roche to help doctors identify patients who can benefit from a lung cancer drug made by the company's Genentech unit.

Idaho spud giant bets on biotech potatoes

3 days ago

"Simplot's Baker pointed to, among other sources, the FDA, which says genetically-engineered foods it reviews meets the same safety requirements as those from traditionally-bred plants.

Federal judge denies FDA effort to block contraceptive access

7 days ago

But Health and Human Services Secretary Kathleen Sebelius overruled the recommendation, and the FDA later rejected a petition calling for unrestricted over-the-counter sales of the drug.

State pharmacy boards back more FDA oversight

8 days ago

State pharmacy boards back more FDA oversight

FDA inspection triggers recall by Florida pharmacy

9 days ago

The St. Petersburg, Fla.-based pharmacy has agreed to recall all of its sterile drugs and is in the process of notifying customers, the FDA said in a statement.

Merck: FDA reviewing its ragweed allergy therapy

9 days ago

In March, the Whitehouse Station, N.J., company said the FDA was reviewing its application for an immunotherapy tablet for grass pollen allergies.

FDA wants cancer warnings on tanning beds

11 days ago

I have to diagnose too many young people with melanoma and see the grief that it causes to these families," said Dr. Mary Maloney of the American Academy of Dermatology, on a call with FDA...

FDA warns pregnant women of migraine drug risk

11 days ago

But the FDA said it is adding new warnings to the drugs' labeling after a study showed they decreased IQ scores in children whose mothers took them while pregnant.

Govt mulls next step on contentious Plan B pill

16 days ago

U.S. District Judge Edward Korman of New York had given the FDA until Monday to lift all age limits on Plan B and a cheaper generic, mandating that emergency contraception be sold just like aspirin.

FDA lowers age limit to 15 for over-the-counter birth control

17 days ago

The U.S. Food and Drug Administration on Tuesday approved the sale of the emergency contraceptive Plan B One-Step for sale without a prescription to women ages 15 and over.

FDA: Morning-after pill to move over-the-counter

17 days ago

Tuesday, the FDA lowered to 15 the age at which girls and women can buy the emergency contraceptive without a prescription - and said it no longer has to be kept behind pharmacy counters.

FDA warns of mold in recalled specialty drugs

60 days ago

The Food and Drug Administration is warning doctors and hospital managers about a nationwide recall of all drugs made by a New Jersey compounding pharmacy because they may be contaminated with mold.

FDA probes new pancreas risks with diabetes drugs

64 days ago

The Food and Drug Administration is looking into evidence that a group of new diabetes drugs can increase the risk of pancreatitis and other problems.

FDA: NJ baking company mislabeled ingredients

65 days ago

The U.S. Food and Drug Administration said Wednesday that Edison-based Butterfly Bakery has agreed under a consent decree to shut down until it can meet all regulations.

FDA adds heart risk warning to popular antibiotic

66 days ago

The FDA's action could convince doctors to choose other options for people prone to heart problems, though the new label notes that some other antibiotics have similar effects on the heart.

FDA head says menu labeling 'thorny' issue

66 days ago

The FDA has tentatively said the rules are due this spring, but that deadline may be optimistic as the food industry and regulators continue to haggle over how they will be written.

Setting a 'just price' for cancer drugs

78 days ago

If prices were set with FDA approval, to help keep rates at what the market can reasonably bear, costs would likely be significantly lower.

FDA Commissioner: budget cuts mean less safe food

78 days ago

The FDA has said the across-the-board cuts due Friday mean 2,100 fewer food safety inspections this year, though Hamburg said in an interview with The Associated Press that the number is an estimate.

FDA OKs drug for painful sex caused by menopause

80 days ago

The Food and Drug Administration on Tuesday approved the first pill-based drug for women who experience pain during sex because of menopause.

FDA halts Amgen study after teen patient death

80 days ago

The FDA says in a statement it is unclear whether Amgen's drug had a role in the patient's death, but it is reminding doctors to prescribe it carefully.

Agency OKs drug to fight breast cancer more gently

84 days ago

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy.

FDA names new head of tobacco products center

84 days ago

A Food and Drug Administration veteran who helped spearhead efforts to regulate the tobacco industry in the 1990s is taking over the agency's Center for Tobacco Products.